Overview

MARCH Renal Substudy

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
Chronic kidney disease (CKD) is an emerging problem in patients with treated HIV. Antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (eGFR). Proteinuria is a key component of CKD and may occur in the absence of significant reductions in eGFR. This substudy is an exploration of changes in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and safety of MVC as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kirby Institute
Treatments:
Abacavir
Atazanavir Sulfate
Darunavir
Dideoxynucleosides
Emtricitabine
Fosamprenavir
HIV Protease Inhibitors
Lamivudine
Lopinavir
Maraviroc
Protease Inhibitors
Reverse Transcriptase Inhibitors
Ritonavir
Tenofovir
Zidovudine
Criteria
Inclusion Criteria:

- Provision of written, informed consent for participation in the substudy

- Enrolled into the substudy either at or before the week 0 visit of the main study